HPV-related Oropharyngeal and Uncommon Cancers Screening (HOUSTON)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02897427|
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : December 20, 2018
|Condition or disease||Intervention/treatment|
|Health Status Unknown||Other: Biomarker Analysis Procedure: Biospecimen Collection Procedure: Ultrasonography|
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|Official Title:||HPV-Related Oropharyngeal and Uncommon Cancers Screening Trial of meN (HOUSTON Study)|
|Actual Study Start Date :||March 28, 2017|
|Estimated Primary Completion Date :||March 28, 2027|
|Estimated Study Completion Date :||March 28, 2027|
Screening (specimen collection, HPV testing)
STAGE I: Participants undergo collection of blood and oral gargle samples.
STAGE II: Participants complete a head and neck exam by using brushing of the oropharyngeal mucosa, a thorough oropharyngeal exam including narrow band imaging, undergo collection of oral gargle sample, transcervical ultrasonography of the neck lymph nodes and oropharynx, anoscopy, and complete Papanicolaou/HPV testing. Participants undergo repeat oropharyngeal screening, oral HPV DNA test, oral HPV integration testing, and ultrasound once every 6 months for 5 years. Participants also undergo collection of blood.
Other: Biomarker Analysis
Complete HPV testing
Procedure: Biospecimen Collection
Undergo collection of blood and oral gargle samples
Undergo transcervical ultrasonography
- Cancer detection rate of the seropositive group [ Time Frame: Up to 5 years ]Will use the proportion equality test to compare the cancer detection rate of the seropositive group using the screening strategy with the historical rate of 0.08 (4/50). To evaluate the performance of the new techniques for early detection, will test whether the proportion of patients diagnosed at stage I, II, or III from the screening strategy is larger than the historical rate of 17.7% using the proportion equality test. Will further compute and compare the pre-cancer detection rates with the historical information.
- Prevalence of serum antibodies to human papillomavirus (HPV)16 E antigens [ Time Frame: Up to 5 years ]Will calculate the prevalence of serum antibodies to HPV16 E antigens along with 95% confidence intervals. Will use descriptive statistics to summarize the demographic and sexual behavior characteristics of study participants overall and by HPV16 E antibody status (positive, negative). Logistic regression models will be used to determine the association between serostatus or oral HPV infection status and demographic, socioeconomic, and behavioral factors.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897427
|Contact: Erich M. Sturgisfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Erich M. Sturgis 713-792-6920|
|Principal Investigator: Erich M. Sturgis|
|Principal Investigator:||Erich Sturgis||M.D. Anderson Cancer Center|